Regulatory Affairs Manager

We are seeking a skilled and experienced Regulatory Affairs Manager to lead our Regulatory Affairs function in Ireland. This role will be responsible for overseeing day-to-day regulatory activities, using expert regulatory CMC capabilities to provide regulatory guidance to the team. This position requires a combination of teamwork with hands-on involvement in regulatory operations, with a particular focus on GMP compliance, regulatory quality assurance, and regulatory CMC-related activities to support our manufacturing site. This position requires management of a small regulatory team.

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• Lead, develop, and manage the local Regulatory Affairs team to ensure high performance, collaboration, and compliance with training and development plans by providing guidance, support, and decision-making assistance.
  
• Support team development through mentoring and knowledge sharing.
  
• Manage departmental budgets and resource allocation to support current and future regulatory requirements.
  

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• Plan, oversee, and actively support the submission of new Marketing Authorisation Applications (MAAs), variations, renewals, and other post-approval activities in the territories assigned, according to the global strategies.
  
• Handle complex regulatory submissions and provide hands-on support for critical projects.
  
• Ensure timely and compliant submissions to EU or other international regulatory agencies, using validated publishing tools.
  

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• Manage and maintain a comprehensive overview of Modules 2.3 and 3 of the dossiers across all applicable territories.
  
• Participate in change control processes to assess the regulatory impact of proposed changes to products, manufacturing processes, or facilities.
  
• Track and evaluate the impact of the CMC changes across different markets.
  
• Lead the preparation and review of the CMC documentation for the products manufactured on site, including the adaptation of CMC sections to meet the specific regulatory requirements of various territories.
  
• Handle complex regulatory submissions and provide hands‑on support for critical projects.
  

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• Maintain regulatory compliance between registered MA dossiers and manufacturing/site operations.
  
• Oversee compliance with regulatory requirements for manufacturing, packaging, testing, and distribution activities.
  
• Review and approve from a regulatory point of view, when necessary, GMP documentation, product artworks, and other regulated documents.
  
• Support Quality Assurance during inspections and audits.
  
• Ensure alignment between regulatory commitments and site operations.
  
• Support preparation of responses to Health Authorities’ queries, in collaboration with other functions, other Helsinn affiliates and/or partners as appropriate.
  

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• Monitor regulatory changes affecting manufacturing operations and implement updates to processes and procedures as necessary.
  
• Support organizational changes and process improvements from a regulatory perspective.
  

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• Serve as the primary contact as MAH representative for interactions between HBP with regulatory authorities (e.g. HPRA, EMA), including attending meetings, managing correspondence, and preparing responses to queries.
  

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• Collaborate closely with Corporate Global Regulatory Affairs to align local activities with global regulatory strategy.
  
• Work closely with Quality, Manufacturing, Supply Chain, R&D, and Commercial teams and provide regulatory guidance and expertise to internal stakeholders.
  
• Provide regulatory support to internal and external stakeholders, including provision of documentation, submission guidance, and communication of regulatory changes.
  

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• A degree in Pharmacy, Life Sciences, or a related discipline. Postgraduate qualifications in Regulatory Affairs or Pharmaceutical Sciences are advantageous.
  
• Minimum of 7 years of relevant experience in Regulatory CMC within the pharmaceutical industry for European or global activities. At least 4 years of experience in CMC regulatory writing and preparing documentation is desirable.
  
• Experience in Regulatory Quality Assurance is highly desirable.
  
• In-depth knowledge of European regulatory requirements (CP, DCP, MRP, national procedures) and familiarity with ROW markets is a plus.
  
• Strong understanding of GMP, GDP, and pharmaceutical quality systems. Previous experience supporting regulatory inspections (GMP, GCP, or regulatory audits).
  
• Proven experience in project management and cross‑functional collaboration.
  
• Strategic and analytical thinking with a proactive approach to regulatory challenges.
  
• Hands‑on approach to regulatory activities with attention to detail.
  
• Excellent communication skills, both written and verbal, with experience interacting with health authorities.
  
• Demonstrated ability to manage multiple projects and deadlines in a dynamic environment.
  
• High attention to detail and commitment to regulatory excellence and compliance.
  
• Problem‑solving skills with a focus on practical solutions. xcfaprz
  
• Important interpersonal and managerial skills, with a focus on team mentoring and development.